Manager

Purpose

The candidate shall be responsible for managing a team of analysts and guiding them in method development, routine analysis and partial method validation to support pharmaceutical formulation development of solid and liquid oral products preferably for ROW market. Additionally, he/she shall be responsible for co-ordination with cross functional teams and other units, documents review, manage and guide the team members, Daily planning, etc.

Position/Job Title

Manager

Department

Analytical Department

Reporting To

General Manager

Location

Thane

Years Of Experience

10-15 years

Dosage Form

Solid and Liquid Orals

Job Responsibilities / Deliverables

Development of stability indicating test methods and other analytical methods as per the dosage form in line with regulatory requirements and smooth transfer to analytical method validation team.

Daly planning of analysis of finished product, Lab stability samples and compatibility study samples.

Evaluation of analytical results and co-ordination with formulation teams.

Review various documents like Specs/STPs/protocols/AMDR.

Provide inputs for finalization of API, excipients, and finished product specifications.

Providing technical inputs based on literature, personal experience and available project documents.

Deliverables

Candidate Shall Be Responsible For

Managing a team of 5-6 Analysts

Guiding the team for all types of analytical activities such as method development. Partial validation, trouble shooting, etc.

Execution of technical deliverables as per target timelines

Strategizing, planning and delegation of work to team members.

Preparation of presentation and attend the internal meetings and review meetings.

Review and ensure adequacy of the technical documents like analytical methods, specifications, method development reports, study protocols etc

Providing inputs for SOP preparation

Ensuring the data integrity and accuracy of supporting data

Monitoring to adherence of GLP compliance by team members

Adherence to quality systems, lab practices to ensure compliance to internal/ external audits

Screening of candidates as per team requirement.

On job training to subordinates and mentor them to fit to company's requirement.

Support to units for OOS and OOT investigations as and when required.

Review of PRs (with justification) for their correctness and follow up with Supply Chain for PO.

Interactions with departments / Teams / Sub functions such as FD, SCM, PMI, QC, DQA, CQA, and IT for requirements of project activities

Coordination with units timely execution of exhibit batches, etc.

Qualifications & Pre-Requisites

Must-Have Qualification and Skills:

MSc. Chemistry/ M. Pharm Pharmaceutical Analysis

Knowledge of interpretation of developed methods on HPLC /GC/PSD/IR.

Current regulatory guidance awareness.

Experience of managing teams

Additional Notes

The candidate is expected to work in any of the shifts as per requirement.

The candidate is expected to visit all sites of Rubicon for Method Transfer/ Investigations as per requirement.